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clinical trial of the effect of raw and cooked milk immunotherapy in children with milk allergy

Phase 2
Conditions
food allergy.
Allergy, unspecified
Registration Number
IRCT20170426033658N2
Lead Sponsor
Vice chancellor for Research of Tehran University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
25
Inclusion Criteria

patients two years and older
Presentation of skin symptoms such as urticaria, erythema and angioedema
gastrointestinal symptoms such as severe vomiting, abdominal pain and diarrhea
respiratory symptoms such as rhinitis and bronchospasm
Presentation of the symptoms up to two hours after exposure
these symptoms should be present at least in last six months
positive skin prick test for cow's milk or measurement of sIgE for cow's milk
positive challenge test with cow's milk

Exclusion Criteria

cellular immune response that is not mediated by IgE
malignancy or severe immunodeficiency disorders
using beta blockers
uncontrolled severe persistent asthma
Cardiovascular disease that epinephrine administration is contraindicated in them
Taking immunosuppressive drugs
previously diagnosed Eosinophilic Gastrointestinal Disorder in response to milk

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Regulatory T cell. Timepoint: Before intervention, after intervention. Method of measurement: Flow cytometry.;Specific IGE for milk. Timepoint: Before intervention, after intervention. Method of measurement: RIDA.;Milk Desensitization. Timepoint: Before intervention, after intervention. Method of measurement: Clinical.
Secondary Outcome Measures
NameTimeMethod
Symptoms,anaphylaxis,desensitization. Timepoint: Immediately after intervention. Method of measurement: physical examination.
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